510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,732
176,529 records, page 2312 of 3531
510(k) clearances, page 2312 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K926430Cannulated Biopsy ForcepsThomasville Medical Assoc.EOQClass II
K926365Magma Xhf-30, Xhf-40, Xhf-50Imaging and X-Ray Intl., Inc.IZOClass I
K926029Infra-LinkZygo Industries, Inc.IQAClass II
K925615Shiley Specialized,pediatric & Neonatal Trach.tubeSorin Biomedica, Fiat, USA, Inc.CBIClass II
K925369Bcd Advanced Blood Carioplegia SystemsSorin Biomedica, Fiat, USA, Inc.DTRClass II
K925326Electrophoresis Control Level 1Seradyn, Inc.JJYClass I
K924642Medtronic Bio-Medicus Femoral Cannula/introducerMedtronic Bio-Medicus, Inc.DWFClass II
K924260Nidek Cv-12000Nidek, Inc.HQCClass II
K923742Topographic Scanning System TopssCarl Zeiss Meditec IncHLIClass II
K923362Reduced Shear Owr Recline SystemLabac Systems, Inc.ITIClass II
K923281Sv 100200 - Single Use Only - Sterile Hospital KitSavoy Medical Supply Co., Inc.MDMClass I
K922214Empty Viaflex Plastic ContainerBaxter Healthcare CorporationKPEClass II
K920882Acuson V714 TransducerAcuson Corp.ITXClass II
K920638Bio-Mate Pic CatheterMedevice, Inc.FOZClass II
K930014Proclinic One-Step Dipstick Pregnancy TestVanguard Biomedical Corp.JHIClass II
K922431Bard Latex Urinary CathetersC.R. Bard IncKODClass II
K930520Theradapt(r) Adjustable Classroom ChairTheradapt Products Inc.INNClass I
K93039816 X 125 Mm Test Tube, Catalog #01-441Proteins Intl., Inc.KIRClass I
K93039716 X 125 Mm Test Tube, CatalogProteins Intl., Inc.KIRClass I
K93039616 X 125 Mm Test Tube, Catalog #01-291Proteins Intl., Inc.KIRClass I
K930395One Dram Shell Vial, Catalog #02-461Proteins Intl., Inc.KIRClass I
K93039425 Cm2, 75 Cm2, A50 Cm2 Flask, Catalog #03-211Proteins Intl., Inc.KIRClass I
K930393One Dram Shell Vial, Catalog #02-261Proteins Intl., Inc.KIRClass I
K93039216 X 125 Mm Test Tube, Catalog #01-111Proteins Intl., Inc.KIRClass I
K93039125 Cm2, 75 Cm2, 150 Cm2 Flask, Catalog #03-261Proteins Intl., Inc.KIRClass I
K93039025 Cm2, 75 Cm2, 125 Cm2 Flask, Catalog #03-291Proteins Intl., Inc.KIRClass I
K930259Traction Table Model #825-200Biodan Medical Systems, Ltd.JFBClass II
K926456Microair Turn-QGsi Development Co.IOQClass II
K926402Comfort Care Low Air Loss Therapy BedCh Administration, Inc.INXClass II
K926316True-Trac, StratusHenley Intl.JFBClass II
K926028BenchesTheradapt Products Inc.INMClass I
K926026DesksTheradapt Products Inc.INWClass I
K925980PmPathfinder Intl. Corp.KNNClass I
K925812Titanium Songer Cable SystemSofamor Danek Mfg., Inc.JDQClass II
K925807Aquaciser in-Pool TreadmillAquaciser, Inc.BXBClass I
K925694Microair PupGsi Medical SystemsIOQClass II
K925451Shadow Rigid WheelchairMagic-In-Motion, Inc.IORClass I
K925329Culturette Brand Toxin Cd TestBD Becton Dickinson Vacutainer Systems PreanalyticLLHClass I
K925164Electric Stand-in TableMidland Mfg. Co.INQClass I
K923942Rhombo Medical Rhombo-FillInternational Medical Products, Inc.KNNClass I
K923365Tilt/reduced Shear Semi-Recline Seating SystemLabsystems, Inc.ITIClass II
K923363Adjustable Sliding Back Power Recline SystemLabac Systems, Inc.ITIClass II
K921028Manual Reclining ChairLabac Systems, Inc.IORClass I
K920819Abdovac (Tm), Bellovac (Tm) and ExudrainAstra Meditec ABGCYClass I
K920629Quinevac IIRecto Molded Products, Inc.FYDClass II
K930415Microhematocrit RotorFisher Scientific Company L.L.C.GKGClass II
K930389One Dram Shell Vial, Catalog #02-291Proteins Intl., Inc.KIRClass I
K93038816 X 125 Mm Test Tube, Catalog #01-241Proteins Intl., Inc.KIRClass I
K930387One Dram Shell Vial, Catalog #02-401Proteins Intl., Inc.KIRClass I
K93038616 X 125 Mm Test Tube, Catalog #01-401Proteins Intl., Inc.KIRClass I